FDA 510(k)

澤尼烏斯脊椎系統

K 號：K170964 · 2017-04-26

決定日期2017-04-26

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Zenius Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey USA, Inc.. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170964. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zenius Spinal System?

Zenius Spinal System is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K170964.

When did Zenius Spinal System receive FDA 510(k) clearance?

Zenius Spinal System received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170964.

Who is the listed applicant for Zenius Spinal System?

The FDA 510(k) record lists Medyssey USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenius Spinal System?

The FDA product code for Zenius Spinal System is NKB.

其他以 Medyssey USA, Inc. 為申請人之記錄

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相關器械（代碼：NKB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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